TOPIRAMATE
- Product NDC
- 61919-883
- Requested package NDC
- 61919-883-30
- 11-digit product format
- 619190883
- Labeler code
- 61919
- Product ID
- 61919-883_b8ba0422-dd85-cd4f-e053-2995a90ad3f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2019-05-31
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 61919-883 | 61919-883-30 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078235-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078235-001 | AB |
| A078235-002 | AB |
| A078235-003 | AB |
| A078235-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078235-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-004 | AB | 1 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5b1b0ba-27f8-4d5d-8943-8aed080fdedc | Product name | 4 | 20260306 |
| 6c26dd6d-01b5-4a80-b096-b3a6f7ca6077 | Product name | 2 | 20250623 |
| cb966f54-bbf0-40fb-b581-80c6648d510c | Product name | 4 | 20250623 |
| 6e2fb0d7-40d7-e97c-1375-fa022ff20193 | Product name | 4 | 20250305 |
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Indexing SPL | Related label |
|---|---|---|
| 61919-883-30 | 2cef2736-75af-d83d-e063-dadaa90ab31f | TOPIRAMATE |
| 61919-883-60 | 2cef2736-75af-d83d-e063-dadaa90ab31f | TOPIRAMATE |
| 61919-883-72 | 2cef2736-9f88-d83d-e063-dadaa90ab31f | TOPIRAMATE |
| 61919-883-86 | 2cef2736-75af-d83d-e063-dadaa90ab31f | TOPIRAMATE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-883-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 | |
| 61919-883-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 4 | |
| 61919-883-86 | TOPIRAMATE | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | 4 | |
| 61919-883-72 | TOPIRAMATE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-883-30 | EA - Each | 61919-883 | cefb26e7-f896-4ea8-ad0b-6b96de71691e | 1 | 2019-07-02 |
| 61919-883-60 | EA - Each | 61919-883 | 879bbe2f-f9fd-42ff-a86f-e283e6065ee3 | 1 | 2020-07-13 |
| 61919-883-72 | EA - Each | 61919-883 | 264c2db8-89cb-461a-8728-303dff4c7193 | 1 | 2019-07-02 |
| 61919-883-86 | EA - Each | 61919-883 | 4b9e9f03-cbe1-449d-b541-2dd4347c4ff1 | 1 | 2023-04-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-883 | TOPIRAMATE TABLET, FILM COATED TOPIRAMATE TABLET [DIRECT_RX] | 4 | Legacy NDC, 3 package rows | 20230316_8a35067c-2f44-52b3-e053-2995a90a6bc1.zip |
| 61919-883 | TOPIRAMATE TABLET, FILM COATED [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190601_8a2f8ea0-bf2c-09b1-e053-2a95a90a105c.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 7e0834ee-920b-496f-954d-f9d81c3ba2d6 | 2026-07-17 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0366164b-1846-443d-9564-dbe52d8d9b65 | 2026-07-08 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 92637f92-9d7c-c246-e053-2995a90a0347 | 2026-06-26 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 9221403c-467f-738e-e053-2995a90ac8fd | 2026-06-26 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 8abe45eb-cc75-4625-ae3d-5b2a038c4907 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | bffcd213-4f09-4a5b-8ccb-591a68be402b | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 57462baf-2f32-4bde-9627-2214c8af9370 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Coupler LLC | 5461f33d-eaef-dce3-e063-6294a90aeff8 | 2026-06-16 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | AvPAK | 53c3f980-f05b-c671-e063-6294a90a77d5 | 2026-06-09 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 6f461f84-bfad-44fa-a2bd-5ea1566444b5 | 2026-05-21 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | b7539f52-06e9-4663-b401-92f5f83653cc | 2026-05-21 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 5ce65b7f-9215-47a8-a784-f87a810bd7e4 | 2026-05-19 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db | 2026-05-19 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 149d20de-f262-4567-aa97-d4d28a1653cb | 2026-04-30 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Quallent Pharmaceuticals Health LLC | 9dae6824-6913-42de-b98a-cdcb0d3b4a46 | 2026-04-25 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | 67dcdd6e-48bc-418e-a887-805929d83ce0 | 2026-04-15 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | afd4c2b9-b80c-b43a-e053-2995a90ac923 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | f3321dc5-0fb7-0d12-e053-2a95a90a9694 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | ffd7be08-050e-dfcb-e053-6394a90ad286 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199888 | topiramate 25 MG Oral Tablet | PSN | 8a35067c-2f44-52b3-e053-2995a90a6bc1 | 4 |
| 151226 | topiramate 50 MG Oral Tablet | PSN | 8a35067c-2f44-52b3-e053-2995a90a6bc1 | 4 |
| 199888 | topiramate 25 MG Oral Tablet | SCD | 8a35067c-2f44-52b3-e053-2995a90a6bc1 | 4 |
| 151226 | topiramate 50 MG Oral Tablet | SCD | 8a35067c-2f44-52b3-e053-2995a90a6bc1 | 4 |
| 199888 | topiramate 25 MG Oral Tablet | PSN | 8a2f8ea0-bf2c-09b1-e053-2a95a90a105c | 1 |
| 199888 | topiramate 25 MG Oral Tablet | SCD | 8a2f8ea0-bf2c-09b1-e053-2a95a90a105c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61919-883-30 | 61919088330 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-883-30) | 2019-05-31 | 0000-00-00 | No | No | Current |